Reviewer, QA Data
About The Position
• Oversee all Analytical and Quality Control (QC) operations, ensuring full compliance with cGMP, FDA, EMA, and ICH regulatory guidelines. • Perform analytical data review, ensuring accuracy, completeness, and timely evaluation of raw data, analytical results, and laboratory documentation. • Ensure data integrity and regulatory compliance by implementing robust review procedures, maintaining audit trails, and enforcing documentation standards. • Collaborate cross-functionally with Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) teams to support analytical method validation, transfer, and troubleshooting. • Review and approve critical analytical documentation, including Certificates of Analysis (CoAs), method validation/verification protocols and reports, and stability study summaries. • Support investigations related to out-of-specification (OOS) results, out-of-trend (OOT) data, deviations, and other laboratory non-conformances. • Drive continuous improvement initiatives across QA/QC systems and processes to enhance operational efficiency and ensure audit readiness. •Operate and troubleshoot HPLC, UPLC, and GC systems, with hands-on proficiency in analytical method development, validation, and routine analysis. • Use and navigate LabWare LIMS, Waters Empower software. • Use Mettler Toledo LabX®- for precision weighing and data integration with analytical balances and titrators, Thermo Scientific OMNIC® (FT-IR) - for spectral acquisition, qualitative analysis, and method execution, Bruker Diffrac.Suite.EVA® (XRD) - for diffraction pattern analysis, phase identification, and crystalline structure evaluation, Metrohm Tiamo® (Potentiometric Titration) - for titration method programming, data acquisition, and result interpretation, Malvern Mastersizer® - for particle size analysis, including method development and particle distribution analysis, and UV-Vis software - for ultraviolet-visible spectroscopy data acquisition, qualitative/quantitative analysis, and spectral evaluation
Requirements
- BS Analytical Chemistry or related
- 60 months as an Analytical Chemist, Chemist- Quality Control or related occupation
Responsibilities
- Oversee all Analytical and Quality Control (QC) operations, ensuring full compliance with cGMP, FDA, EMA, and ICH regulatory guidelines.
- Perform analytical data review, ensuring accuracy, completeness, and timely evaluation of raw data, analytical results, and laboratory documentation.
- Ensure data integrity and regulatory compliance by implementing robust review procedures, maintaining audit trails, and enforcing documentation standards.
- Collaborate cross-functionally with Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) teams to support analytical method validation, transfer, and troubleshooting.
- Review and approve critical analytical documentation, including Certificates of Analysis (CoAs), method validation/verification protocols and reports, and stability study summaries.
- Support investigations related to out-of-specification (OOS) results, out-of-trend (OOT) data, deviations, and other laboratory non-conformances.
- Drive continuous improvement initiatives across QA/QC systems and processes to enhance operational efficiency and ensure audit readiness.
- Operate and troubleshoot HPLC, UPLC, and GC systems, with hands-on proficiency in analytical method development, validation, and routine analysis.
- Use and navigate LabWare LIMS, Waters Empower software.
- Use Mettler Toledo LabX®- for precision weighing and data integration with analytical balances and titrators, Thermo Scientific OMNIC® (FT-IR) - for spectral acquisition, qualitative analysis, and method execution, Bruker Diffrac.Suite.EVA® (XRD) - for diffraction pattern analysis, phase identification, and crystalline structure evaluation, Metrohm Tiamo® (Potentiometric Titration) - for titration method programming, data acquisition, and result interpretation, Malvern Mastersizer® - for particle size analysis, including method development and particle distribution analysis, and UV-Vis software - for ultraviolet-visible spectroscopy data acquisition, qualitative/quantitative analysis, and spectral evaluation
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
